Severe osteoporosis figures likely to rise with ageing population
The percentage of the population over the age of 60 will reach 16.3% by 2040. [https://doi.org/10.1007/978-981-10-1458-1_88 Accessed 9 December 2021] As a result, the number of women susceptible to osteoporosis is likely to increase in tandem, as menopause is the primary risk factor for the condition.
Osteoporosis is a condition in which a person’s bone mass decreases, resulting in fragile bones. Dato’ Dr Lee Joon Kiong, consultant orthopaedic surgeon, said: “We know that osteoporosis is a major cause of fractures among postmenopausal women. Those who already have an osteoporotic fracture are at a high risk of a subsequent fracture if they are not started on an appropriate treatment regimen.”
“As surgeons and doctors, we are always looking for innovative drugs that offer a superior treatment option and can help us give our patients a better quality of life. I would advise women with severe postmenopausal osteoporosis to talk to their doctors and determine the best treatment option for them to reduce their risk of future fractures,” added Lee who is also president of the Fragility Fracture Network of Malaysia (FFNM) and founding member of the Bone Health Alliance Malaysia (BHAM). Severe osteoporosis refers osteoporosis that has been confirmed in the presence of one or more documented fragility fractures. [Available at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5335887 Accessed on 10 December 2021]
Professor Serge Ferrari, head of the Service of Bone Diseases, Geneva University Hospital, Switzerland, echoed Lee’s caution of a second fracture should patients not receive proper or effective intervention after the first fracture. He suggested the use of a bone-forming agent in patients at high risk of initial fracture. Patients at high risk of initial fracture are those who are: >65 years old, with prevalent osteoporotic fracture, very low bone mass (T score ≤ -3), secondary or primary osteoporosis associated with disease that can result in high risk of fracture due to various causes, medical conditions that increases the risk of a fall, on medications that increase risk of bone loss, and long term institutionalization (leading to lack of sunlight and exercise). [Drugs R D 2012 Dec; 12(4): 199–206]
Lee and Ferrari were speaking at the launch of romosozumab (EVENITY®, Amgen) a biologic agent that increases bone formation and simultaneously decreases bone resorption—resulting in a net increase in bone mineral density. [Romosozumab Malaysia PI, May 2021] The drug is indicated for women with severe postmenopausal osteoporosis.
Romosozumab’s approval is powered by the FRActure Study In Postmenopausal WoMen With OstEoporosis (FRAME) trial, which is a randomized, double-blind, placebo-controlled study with 7,180 participants comprising postmenopausal women with osteoporosis. The primary endpoints were the cumulative incidences of new vertebral fractures at 12 months and 24 months while secondary endpoints included composite of nonvertebral and symptomatic vertebral, and nonvertebral fractures. At 12 months, new vertebral fractures had occurred in 0.5 percent of participants in the romosozumab group, as compared with 1.8 percent in the placebo group (representing a 73 percent risk reduction in the romosozumab group; p<0.001). Clinical fractures (a composite of nonvertebral fracture and symptomatic vertebral fracture) had occurred in 1.6 percent of participants in the romosozumab group, as compared with 2.5 percent in the placebo group (a 36 percent risk reduction with romosozumab; p=0.008). Nonvertebral fractures had occurred in 1.6 percent of participants in the romosozumab group and in 2.1 percent in the placebo group (p=0.10). At 24 months, vertebral fracture rates were significantly lower in the romosozumab group than the placebo group (0.6 percent vs 2.5 percent, respectively). [N Engl J Med 2016;375:1532–1543]
“Often, osteoporosis gets overlooked even though it can lead to devastating consequences. We recognize the critical importance of protecting bone health and preventing fragility fractures as women enter the postmenopausal phase of their life. Amgen is one of the leaders in bone health, and we are committed to bringing effective treatments to support patients suffering from osteoporosis,” said Colin Chan, general manager of Amgen Malaysia. “We believe that women with severe postmenopausal osteoporosis in Malaysia will stand to benefit from the option of a new bone-forming agent like EVENITY, in turn helping to address this important treatment gap.”
Romosozumab contains a boxed warning on its labeling stating that it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year. Health care professionals should consider whether the benefits of this drug outweigh its risks in those with other risk factors for heart disease and should discontinue treatment in any patient who experiences a heart attack or stroke during treatment.